Morbid Obesity is a serious health problem that affects more than 4 million people in the U.S.A. In Spain, it is calculated that it affects 2% of the population and is progressively more frequent, just as it is world level. Morbid Obesity decreases the life expectance of the subjects that by merely suffer it “per se”, but also as a predisposing factor of other pathologies, such as diabetes mellitus, arterial hypertension, myocardial ischemia, obstructive sleep apnoea syndrome (O.S.A.S., osteo-articular pathology . . . )
The only efficient treatment is Surgery, that is indicated when the Body Mass Index (B.M.I.) is greater than 40 (B.M.I.=Weight in Kg/Height in m2) or when the B.M.I. is greater than 35, when the so-called co-morbidities exist (hypertension, diabetes, myocardial ischemia, O.S.A.S . . . ).
Among the most used surgical treatments, we highlight Vertical Band Gastroplasty (V.B.G.), which consists of producing a small gastric reservoir that causes the patient to experience “early satiation” in the ingestion of food, therefore restricting the capacity for gastric ingestion and storage, with which a very considerable loss of weight is achieved.
The V.B.G. is a simple and efficient technique in the decade of the eighteenths and supposed more than 80% of the baryatric surgery interventions in the U.S.A., but presented a serious problem that has still not been satisfactorily resolved: the elimination of the staples, that condition the production of reservoir-gastric fistulas and which, in the final term, lead the patient regaining weight. This has had an influence on the resurgence or search of other more complex alternative surgeries (Gastric by-pass, sphincter of Oddi derivation, . . . ) with greater surgical risk.
The V.B.G. (FIG. 1) consists of vertical gastric stapling (2) (performed by means of the baryatric stapler) parallel to the minor curvature, with a previous preparation of a “gastric window” (1) in 6-7 cm of oesophageal-gastric union which, as well as permitting the later stapling of the viscera, permits the location of a band (3) (Marlex, P.T.F.E. . .) that notably decreases the capacity of gastric filling, limiting it to the small gastric reservoir (4) and, in the final term, making it difficult for food to pass to the rest of the viscera.
The gastric stapling is performed with the baryatric A.T. that establishes 4 rows of metal staples and some authors have employed double staples (8 rows of staples, partially over-imposed), to avoid the after reservoir-gastric fistulas previously mentioned where possible. This approach decreased the incidence by 15%-20% to 5%-10%, but did not eliminate it completely.
Some American patents have designed instruments for executing gastroplasties:
Hopkins in 1982 (U.S. Pat. No. 4,458,681) designed a clamp for performing a horizontal Gastroplasty, with a separation of the two plates in the central area, to permit food to pass to the distal gastric area. To my knowledge, this has not been used in a clinic. In any case, horizontal gastroplasties in general have not demonstrated any efficiency in the treatment for Morbid Obesity.
More recently, Bessler in 1995 (U.S. Pat. No. 5,549,621) designed a sophisticated instrument to perform a V.B.G. that includes two metal bars that have penetrating points that protrude from the first clamp, to join the “receiver” clamp, totally crossing the gastric wall. This instrument includes the V.B.G. exit band. To my knowledge, it has not been used in a clinic. In neither of the descriptions did the instrument have an external curvilinear configuration, with blunt edges nor is it covered with a material that cushions the pressure of the plates or bars. In neither of the descriptions did the instrument have an external curvilinear configuration, with blunt edges nor is it covered with a material that cushions the pressure of the plates or bars.
Thus, the present alternative in Surgery to the instrument that is the object of the invention is the baryatric Stapler, that locates the metal staplers and the plates with points that completely cross the gastric wall (with respect to the last instrument, no clinical experience exists).